Breast Cancer - GDC-0032 - PIK3CA mutation

Association details:

Biomarker:	PIK3CA mutation
Cancer:	Breast Cancer
Drug:	taselisib (GDC-0032) (PI3Kα inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Excerpt:

...- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing...

Trial ID:

SANDPIPER

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Excerpt:

...- Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is - Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer - Recurrence or progression during or after aromatase inhibitor - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas® PIK3CA mutation result by central testing is required - Adequate hematologic and end-organ function within 28 days prior to treatment initiation ...

Trial ID:

NCT02313948

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)

Excerpt:

...- Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol...

Trial ID:

NCT04439175

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Excerpt:

...- Phase I (Cohort T): Participants with non-Hodgkin's lymphoma, regardless of PIK3CA mutation status...

Trial ID:

NCT01296555

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Excerpt:

...- Tumor tissue from formalin-fixed paraffin-embedded cores (FFPE) core biopsy of breast primary tumor that is confirmed as evaluable for phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation status by central histopathology laboratory...

Trial ID:

LORELEI

Evidence Level:

Sensitive: D – Preclinical

Source:

ASCO 2020

Title:

Test measuring signaling activity in live patient tumor cells to identify PI3KCA WT patients who may benefit from PI3K inhibitors.

Published date:

05/28/2020

Excerpt:

For the xenograft study, 16 NSG mice were injected with HCC1954 PIK3CA mutated breast cancer cells and randomly assigned to either the control or taselisib group (10 mg/kg)….The xenograft study reported here using HCC1954 cells found taselisib induces a significant anti-tumor effect (T/C ratio = 0.21; p = 0.009; t-test).

DOI:

10.1200/JCO.2020.38.15_suppl.e13000